Epirubicin Ebewe

Epirubicin Ebewe Dosage/Direction for Use



EBEWE Pharma




Mega Lifesciences
Full Prescribing Info
Dosage/Direction for Use
Epirubicin hydrochloride is for intravenous or intravesical use only.
The safety and efficacy of epirubicin hydrochloride in children has not been established.
Intravenous administration: It is advisable to administer epirubicin hydrochloride via the tubing of a freely-running intravenous saline infusion after checking that the needle is properly placed in the vein. This method minimises the risk of drug extravasation and makes sure that the vein is flushed with saline after the administration of the medicinal product. Extravasation of epirubicin hydrochloride from the vein during injection may give rise to severe tissue lesions, even necrosis. Venous sclerosis may result from injection into small vessels or repeated injections into the same vein.
Conventional doses: When epirubicin hydrochloride is used as a single agent, the recommended dose in adults is 60-90 mg/m2 body area; the medicinal product should be injected intravenously over 3-5 minutes and, depending on the patient's haematomedullary status, the dose should be repeated at 21-day intervals.
High doses: Epirubicin hydrochloride as a single agent for the treatment of lung cancer at high doses should be administered according to the following regimens: Lung cancer: Small cell lung cancer (previously untreated): 120 mg/m2 epirubicin hydrochloride day 1, every 3 weeks.
Non-small cell lung cancer (squamous, large cell, and adenocarcinoma previously untreated): 135 mg/m2 epirubicin hydrochloride day 1 or 45 mg/m2 epirubicin hydrochloride days 1, 2, 3, every 3 weeks.
Breast cancer: In the adjuvant treatment of early breast cancer patients with positive lymph nodes, intravenous doses of epirubicin hydrochloride ranging from 100 mg/m2 (as a single dose on day 1) to 120 mg/m2 (in two divided doses on days 1 and 8) every 3-4 weeks, in combination with intravenous cyclophosphamide and 5-fluorouracil and oral tamoxifen, are recommended.
The medicinal product should be given as an intravenous bolus over 3-5 minutes or as an infusion up to 30 minutes. Lower doses (60-75 mg/m2 for conventional treatment and 105-120 mg/m2 for high dose schedules) are recommended for patients whose bone marrow function has already been impaired by previous chemotherapy or radiotherapy, by age, or neoplastic bone-marrow infiltration. The total dose per cycle may be divided over 2-3 successive days.
When the medicinal product is used in combination with other antitumour agents, the doses need to be adequately reduced.
Impaired liver function: Since the major route of elimination of epirubicin hydrochloride is the hepatobiliary system, the dose should be reduced in patients with impaired liver function, in order to avoid an increase of overall toxicity. Moderate liver impairment (bilirubin: 1.4 - 3 mg/100 ml) requires a 50% reduction of dose, while severe impairment (bilirubin >3 mg/100 ml) necessitates a dose reduction of 75%.
Impaired renal function: Moderate renal impairment does not appear to require a dose reduction in view of the limited amount of epirubicin hydrochloride excreted by this route. However dose adjustment may be necessary in patients with serum creatinine >5 mg/dl.
Intravesical administration: Epirubicin hydrochloride can be given by intravesical administration for the treatment of superficial bladder cancer and carcinoma-in-situ. It should not be used in this way for the treatment of invasive tumours which have penetrated the bladder wall where systemic therapy or surgery is more appropriate. Epirubicin hydrochloride has also been successfully used intravesically as a prophylactic agent after transurethral resection of superficial tumours in order to prevent recurrences.
While many regimens have been used, the following may be helpful as a guide: for therapy, 8 x weekly instillations of 50 mg/50 ml (diluted with saline or distilled sterile water). In the case of local toxicity (chemical cystitis), a dose reduction to 30 mg/50 ml is advised. For carcinoma-in-situ, depending on the individual tolerability of the patient, the dose may be increased up to 80 mg/50 ml. For prophylaxis, 4 x weekly administrations of 50 mg/50 ml, followed by 11 x monthly instillations at the same dose, is the schedule most commonly used.
The solution should be retained intravesically for 1 hour. To avoid undue dilution with urine, the patient should be instructed not to drink any fluid in the 12 hours prior to instillation. During the instillation, the patient should be rotated occasionally and should be instructed to void urine at the end of the instillation time.
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